Lubricant Eye Drops

Manufacturer
MFB Global LLC | DrSignal BioTechnology Co., Ltd.
Effective date
2021-11-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:44:49

Label at a glance#

ProductLubricant Eye Drops
Active ingredientHYALURONATE SODIUM, PYRIDOXINE HYDROCHLORIDE
Label structure16 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Sodium Hyaluronate 1%

OTC - PURPOSE SECTION

Lubricant

DOSAGE & ADMINISTRATION SECTION

For the temporary relief of burning and irritation due to dryness of the eye.

For the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun.

For use as a protectant against further irritation or to relieve dryness of the eye.

For use as a lubricant to prevent further irritation or to relieve dryness of the eye.

Relieves redness of the eye due to minor eye irritations.

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

if solution changes color or becomes cloudy.

USER SAFETY WARNINGS SECTION

if you have narrow angle glaucoma.

OTC - WHEN USING SECTION

To avoid contamination, do not touch tip of container to any surface. ■ Replace cap after using. ■ Overuse of this product may produce increased redness of the eye. ■ Pupils may become enlarged temporarily.

OTC - ASK DOCTOR SECTION

if ■ you experience eye pain, changes in vision, continued redness or irritation of the eye. ■ the symptom worsens or persists for more than 72 hours.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help of contact a Poison Control Center right away.

INDICATIONS & USAGE SECTION

Instill 1 or 2 drops in the affected eye(s) as needed up to four times daily.

OTHER SAFETY INFORMATION

Keep refrigerated. Store at 4-10℃(39-50℉). ■ Tamper Evident. Do not use if ring around the bottom of bottle cap is broken or missingminor eye irritations.

INACTIVE INGREDIENT SECTION

Polyquaternium 1

Purified Water.

PATIENT COUNSELING INFORMATION

1-646-339-5789

SPL UNCLASSIFIED SECTION

Manufacturer: DrSignal BioTechnology Co., Ltd. (No. 2-1, Ln. 181, Sec. 2, Jiuzong Rd., Neihu Dist., Taipei City 114, Taiwan)
Distributor: MFB Global LLC
(136-17 39th Ave Suite 301, Flushing, NY 11354, USA) Tel: 1-646-339-5789


Made in Taiwan

DESCRIPTION SECTION

product information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

refer to following imagerefer to following image

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
PYRIDOXINE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20170310

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82357-1101-22023-01-30C16284748780-1f386c649-d826-0266-e053-dadaa90a7c1acfb13935-6e77-73f0-e053-2a95a90ab3c5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82357-1101-1Lubricant Eye Drops3 mL in 1 BOTTLE, PLASTICSOLUTION/ DROPS32
82357-1101-2Lubricant Eye Drops1 in 1 BOXSOLUTION/ DROPS12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82357-1101LUBRICANT EYE DROPS (SODIUM HYALURONATE) SOLUTION/ DROPS [MFB GLOBAL LLC]2Legacy NDC, 2 package rows20211109_cfb13935-6e77-73f0-e053-2a95a90ab3c5.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82357-110182357-1101-1, 82357-1101-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d03d3be9-d867-2aad-e053-2995a90aec8ccfb13935-6e77-73f0-e053-2a95a90ab3c52021-11-07WarningsExact identifier
spl id: d03d3be9-d867-2aad-e053-2995a90aec8c
spl set id: cfb13935-6e77-73f0-e053-2a95a90ab3c5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.